QA Compliance Specialist - 12 month contract

SmartRecruiters, Inc.; Sligo; On-site; EUR 60,000 - 75,000; Full time

Job summary

AbbVie is seeking a QA Compliance Specialist for a 12-month contract at our Sligo site. The role ensures new products transferred to AbbVie Ireland NL B.V.

are compliant with regulatory requirements and internal procedures. You will support the transfer of new products from development through commercialization, working with cross-functional teams to address quality concerns and maintain site-wide compliance.

Qualifications

• Third level qualification in science, quality or related field.
• Minimum three years of quality experience supporting new product introductions.
• Strong knowledge of regulatory requirements.

Responsibilities

• Ensure new products transferred to AbbVie Ireland NL B.V. meet regulatory and internal requirements.
• Maintain effectiveness of integrating new products into the NPI quality system.
• Support vendor evaluation and management of technical agreements from initiation to storage.
• Review and approve NPI-related Analytical Test Method transfers and validation.
• Collaborate with CMC QA, R&D, S&T and other functions to address quality concerns.
• Coordinate site review of material specifications (API, Drug Product, excipients, etc.).
• Support generation and handling of exception documentation including CAPAs.
• Interface with internal auditors and external regulatory bodies as SME.

Skills

Regulatory compliance

Quality systems

New product introduction

Cross-functional collaboration

Documentation management

Education

Science/Quality degree

Job description

QA Compliance Specialist - 12 month contract

• Full-time
• Workday Global Grade: 14

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

TheNPICompliance Specialistis responsible forensuring new products transferred to AbbVie Sligo are manufactured in accordance with applicable regulatory requirements and AbbVie procedures and policies. To ensure effective and compliant transfer of New Products to the site.

Responsibilities:

Responsible for maintaining the effectiveness of the integration of new products into the AbbVie NPI quality system.

Ensuring that new products manufactured at AbbVie Ireland NL B.V. meet requirementsof applicable regulatory requirements and AbbVie procedures and policies.

NPI Compliance Specialist isresponsible forsupportingnew product transfers to the site from development through to commercialization, liaising closely with local and external cross functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.

Support vendor evaluation and approval,management of all technical agreements from initiation, review, approval, and storage.

Support review and approval of NPI related Analytical Test Method Transfers and / or validation.

Collaborate with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality complianceand provide input on quality concerns.

Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug Product specifications, raw material specifications, and excipient specifications.

Support review and approval of new product related analytical Test Method Transfers and/or validation.

Support the management of new product related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.

Generation of product transfer documentation to attest the completion of product transfer deliverables, in advance of the applicable product transfer stage gate review.

Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matterexpertfor new products and technology transfers.

Adheres to and supports all EHS & E standards, procedures and policies

• AThird level qualification ina science, quality or relevant discipline.

A minimum ofthreeyears’ experienceina qualityrolesupporting new product introductions.

A strong knowledge of regulatory requirements is required

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.